INSIDE HEALTH CARE.

Drug for gout works well in test, TAP says

October 21, 2004|By BRUCE JAPSEN.

A Lake Forest drugmaker's experimental treatment for gout may offer patients the first new advancement for the condition in four decades.

A final-phase clinical trial of TAP Pharmaceutical Products Inc.'s febuxostat shows the drug works better than a current widely used therapy at lowering levels of uric acid, according to new data presented at this week's American College of Rheumatology meeting in San Antonio.

High levels of uric acid in the body are typically associated with gout, an inflammatory form of arthritis most common in men over the age of 40. More than 5 million Americans suffer from gout, which is characterized by intense pain, inflammation and warmth in affected joints.

"This would be the newest [treatment] initiative . . . in some 40 years," said Dr. Michael Becker, a rheumatologist and professor of medicine at the University of Chicago.

Becker, who is a paid consultant to TAP and has worked with other drugmakers who have tried to develop new gout treatments, said most current therapies are older generic drugs that are limited in their effectiveness and tolerance in the body.

In the new data presented by clinical researchers this week, 53 percent of patients taking an 80 milligram dose of febuxostat achieved uric acid levels below six milligrams per deciliter--a level considered normal and one resulting in fewer flare-ups of the symptoms.

"The study showed febuxostat to be well-tolerated among patients with gout," said Dr. Ralph Schumacher, professor of medicine at the University of Pennsylvania and a TAP-paid investigator involved in the study.

The study data are expected to be used as part of TAP's submission of febuxostat sometime in the fourth quarter of this year to the Food and Drug Administration for possible approval sometime next year.

Should febuxostat reach the market, it would be a milestone for TAP.

The company has not had a major drug approved by U.S. regulators since the heartburn medicine Prevacid won FDA approval in 1995.

Prevacid has been a blockbuster for TAP, but sales are dropping in the face of stiff competition among other heartburn treatments. In the first nine months of this year, Prevacid sales dropped 10 percent, to $2.1 billion, from the same period last year.

Because TAP does not have its own research pipeline, it licenses drugs from other companies and develops and markets them in the United States. TAP licensed febuxostat in 1999 from Tokyo-based Teijin Ltd.

Some analysts believe febuxostat could generate more than $500 million simply as a treatment for managing high uric acid levels in the treatment of gout.

TAP is a joint venture of North Chicago-based Abbott Laboratories and Japan's largest drugmaker, Takeda Pharmaceutical Co. Ltd.